The health ministry said Thursday that a patient taking the cancer drug Opdivo has died and that it has ordered the manufacturer to add a warning on the package insert about a serious side effect.
The patient was among 11 who experienced pituitary disorders after being treated with Opdivo, which is made by Ono Pharmaceutical Co.
The medicine, which stimulates the body’s immune system to fight cancer cells, was developed based on research by Kyoto University professor Tasuku Honjo. He was jointly awarded the 2018 Nobel Prize in Physiology or Medicine for the research.
The 11 patients experienced abnormalities in the pituitary gland, which produces growth and other hormones.
The current package insert calls on recipients to take regular pituitary tests while taking the medicine.
Ono Pharmaceutical said that, given the drug’s effect of strengthening the body’s immune response, the possibility cannot be ruled out that its use triggered the dysfunctions.
While a link between the death and the drug has not been established, a spokesperson for the firm acknowledged that there had been deaths in the past in which the administration of Opdivo could not be ruled out as a cause, and that the warnings on the package insert were being revised.
At a news conference announcing the firm’s financial results, Ono Pharmaceutical President Gyo Sagara said that Opdivo is currently administered in 17,000 to 18,000 cases each year, adding that the firm plans to expand the sales of the drug.